Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

Many excuses center around the need for local people to be able to claim that they know something that the evidence does not show, although they consistently fail to provide valid evidence for these claims. This local knowledge appears to be intuitive – they just know it, but cannot provide anything to support their feelings.

The latest research can be interpreted in many different ways, but it definitely does not support the claims of the advocates of parochialism.

MOR = Median Odds Ratio – how many times more likely is something to happen.

What is most commonly measured is what matters the least – ROSC (Return Of Spontaneous Circulation). Did we get a pulse back, for even the briefest period of time, regardless of outcomes that matter.

What matters? Does the person wake up and have the ability to function as they did before the cardiac arrest.

Those who justify focusing on ROSC claim that, If we don’t get a pulse back, nothing else matters, but that is the kind of excuse used by frauds. How we get a pulse back does matter. The evidence makes that conclusion irrefutable, but there will always be those who do not accept that they are causing harm. They will make excuses for the harm they are causing. Getting ROSC helps them to feel that they are not causing harm. ROSC encourages us to give drugs like epinephrine, which have been demonstrated to not improve any survival that matters.

The means of obtaining ROSC can be compared to the means of doing anything that requires finesse. Sure, it feels good to try to force something. Sure, you can claim that forcing something is the most direct way to accomplish the goal.

Can the advocates of focusing on ROSC produce any valid evidence that their approach leads to improvements in outcomes that matter? No. The evidence contradicts their claims. The evidence has caused us to eliminate many of their treatments – treatments they claimed had to work because of physiology. As it turns out, they were wrong. They were wrong about their treatments and wrong about their understanding of physiology.

If you want to win money, bet that any new treatment will not improve outcomes that matter.

Is presence of a pulse upon arrival at the emergency department an important outcome? Only for billing purposes. The presence of a pulse justifies providing more, and more expensive, treatments. Is the presence of a pulse upon arrival at the emergency department a goal worth trying for? As with ROSC, only if it does not cause us to harm patients to obtain this goal, which is just something that is documented, because it is a point of transfer of patient care.

After restricting analysis to those who survived more than 60 minutes after hospital arrival and including hospital treatment characteristics, the variation persisted (adjusted MOR for survival, 1.49 [95% CI, 1.36-1.69]; adjusted MOR for functionally favorable survival, 1.34 [95% CI, 1.20-1.59]).[1]

There is a lot of variability.

What did they find?

Most of the people in EMS, who claim to be doing what is best for their patients, are making things worse.

69% means that there are two EMS agencies producing bad outcomes for every EMS agency producing good outcomes.

Correction – The text crossed out is not accurate. I should have thought that through a bit better before I posted it. My caption for Table 1 is accurate. However, what I should have written afterward is –

The worse half of EMS agencies are only producing half as many good outcomes as the better half of EMS agencies.

We are bad at resuscitation and those doing the most resuscitating are doing the least good.

Why do so many of us refuse to improve our standards?

What is more important than the outcomes for our patients?

Why are we so overwhelmingly bad at resuscitation?

What are the authors’ conclusions?

This study has implications for improvement of OHCA management. First, the analysis indicates that the highest-performing EMS agencies had more layperson interventions and more EMS personnel on scene.[1]

They do not conclude that we need more doctors, more nurses, or more paramedics responding to cardiac arrest.

Second, our findings justify further efforts to identify potentially modifiable factors that may explain this residual variation in outcomes and could be targets of public health interventions.[1]

We need to figure out what we are doing, because the people telling us that they know that we need intubation are lying.

We need to figure out what we are doing, because the people telling us that they know that we need epinephrine are lying.

We need to figure out what we are doing, because the people telling us that they know that we need amiodarone are lying.

We need to figure out what we are doing, because the people telling us that they know that we need ________ are lying.

How dare I call them liars?

Let them produce valid evidence that the interventions they claim are necessary actually do improve outcomes that matter.

Have them stop making excuses and start producing results.

I dare them.

The only time we have made significant improvements in outcomes have been when we emphasized chest compressions, especially bystander chest compressions, and when we emphasized bystander defibrillation.

It is time to start requiring evidence of benefit for everything we do to patients.

Our patients are too important to be subjected to witchcraft, based on opinions and an absence of research.

There is plenty of valid evidence that using only chest compressions improves outcomes.

Do we have to stop using epinephrine (adrenaline in Commonwealth countries) for cardiac arrest?

PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest) compared adrenaline (epinephrine) with placebo in a “randomized, double-blind trial involving 8014 patients with out-of-hospital cardiac arrest”.[1]

The results showed that 1 mg of epinephrine every 3 – 5 minutes is even worse than I expected, but a lot of the more literate doctors have not been using epinephrine that way. What does this research tell us about their various methods? The podcast REBEL Cast (Rational Evidence Based Evaluation of Literature in Emergency Medicine) has a discussion of this question in REBEL Cast Ep56 – PARAMEDIC-2: Time to Abandon Epinephrine in OHCA?.[2]

The current ACLS/ILCOR (Advanced Cardiac Life Support/International Liaison Committee on Resuscitation) advice on epinephrine does not state that epinephrine is a good idea, or even require that you give epinephrine to follow their protocol –

The major changes in the 2015 ACLS guidelines include recommendations about prognostication during CPR based on exhaled CO2 measurements, timing of epinephrine administration stratified by shockable or nonshockable rhythms, and the possibility of bundling treatment of steroids, vasopressin, and epinephrine for treatment of in-hospital arrests. In addition, the administration of vasopressin as the sole vasoactive drug during CPR has been removed from the algorithm.[3]

What was the ACLS/ILCOR advice in the 2010 guidelines?

The 2010 Guidelines stated that it is reasonable to consider administering a 1-mg dose of IV/IO epinephrine every 3 to 5 minutes during adult cardiac arrest.[4]

This is in a paragraph that links to the PICO (Population-Intervention-Comparator-Outcomes) question that has been an open question for over half a century – In cardiac arrest, is giving epinephrine better than not giving epinephrine?[5]

Again, ACLS/ILCOR only considered a dose of epinephrine to be reasonable. Again, this was based on low quality evidence. I am not criticizing the efforts of those who worked on the Jacobs study of adrenaline vs. placebo, because they were stopped by the willfully ignorant opponents of science.[7]

What about the method of attempting to titrate an infusion to the hemodynamic response, which Dr. Swaminathan and Dr. Rezaie alluded to?

There is a lot of anecdotal enthusiasm from doctors who use this method, but I do not know of any research that has been published comparing outcomes using this method with anything else. How do we know that the positive reports from doctors are anything other than confirmation bias? We don’t.

This year is the 200th anniversary of the publication of the very first horror novel – Frankenstein; or, The Modern Prometheus. The doctor in the novel used electricity to raise the dead (and the subjects were very dead). There were no chest compressions in the novel, but it is interesting that we have barely made progress from the fiction imagined by an 18 year old with no medical training, although she did have the opportunity to listen to many of the smartest people in England discuss science. Mary Godwin (later Mary Wollstonecraft Shelley by marriage) was 16 when she started writing the novel.[8]

We have barely made more progress at resuscitation than a teenager did 200 years ago in a novel. Most of our progress has been in finally admitting that the treatments we have been using have been producing more harm than benefit. Many of us are not even that honest about the harm we continue to cause.

We dramatically improved resuscitation in one giant leap – when we focused on high quality chest compressions and ignoring the medical theater of advanced life support.

There are two treatments that work during cardiac arrest – high quality chest compressions and rapid defibrillation.

Why haven’t we made more progress?

We have been too busty making excuses for remaining ignorant.

We need to stop being so proud of our ignorance.

We now know that amiodarone doesn’t work for cardiac arrest (and is more dangerous than beneficial for ventricular tachycardia – even adenosine appears to be better for VTach), atropine doesn’t work for cardiac arrest, calcium chloride doesn’t work for cardiac arrest (unless it is due to hyperkalemia/rhabdomyolysis), vasopressin doesn’t work for cardiac arrest, high dose epinephrine doesn’t work for cardiac arrest, standard dose epinephrine doesn’t work for cardiac arrest – in other words, we have tried all sorts of drugs, based on hunches and the weakest of evidence, but we still haven’t learned that there isn’t a magic resuscitation drug.

Should anyone be using any epinephrine to treat cardiac arrest outside of a well controlled study?

Among adults who are in cardiac arrest in any setting (P), does does the use of epinephrine (I), compared with compared with placebo or not using epinephrine (C), change Survival with Favorable neurological/functional outcome at discharge, 30 days, 60 days, 180 days AND/OR 1 year, Survival only at discharge, 30 days, 60 days, 180 days AND/OR 1 year, ROSC (O)?

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

As part of a study to find out if epinephrine (adrenaline in Commonwealth countries) is safe to use in cardiac arrest, a patient was treated with a placebo, rather than the inadequately tested drug. Some people are upset that the patient did not receive the drug they know nothing about.[1]

The critics are trying to make sure that we never learn.

We need to find out how much harm epinephrine causes, rather than make assumptions based on prejudices.

When used in cardiac arrest, does epinephrine produce a pulse more often?

Yes.

When used in cardiac arrest, does epinephrine produce a good outcome more often?

We don’t know.

In over half a century of use in cardiac arrest, we have not bothered to find out.

We did try to find out one time, but the media and politicians stopped it.[2]

We would rather harm patients with unreasonable hope, than find out how much harm we are causing to patients.

We would rather continue to be part of a huge, uncontrolled, unapproved, undeclared, undocumented, unethical experiment, than find out what works.

Have we given informed consent to that kind of experimentation?

Ignorance is bliss.

The good news is that the enrollment of patients has finished, so the media and politicians will not be able to prevent us from learning the little that we will be able to learn from this research.[3]

Will the results tell us which patients are harmed by epinephrine?

Probably not – that will require a willingness to admit the limits of what we learn and more research.

What EMS treatments have been demonstrated to improve outcomes from cardiac arrest?

1. High quality chest compressions.2. Defibrillation, when indicated.

Nothing else.

All other treatments, when tested, have failed to be better than nothing (placebo).

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

Trial Update – 19 February 2018:
PARAMEDIC2 has finished recruitment and we are therefore no longer issuing ‘No Study’ bracelets. The data collected from the trial is in the process of being analysed and we expect to publish the results in 2018. Once the results have been published, a summary will be provided on the trial website.

–

Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 2.

Acupuncture has been thoroughly studied in high quality studies. The result is that we know, yes we know, that acupuncture is just an elaborate placebo – a scam. A reputable journal is claiming that low quality evidence contradicts what we know and we should ignore the high quality evidence.[1]

So why did the Medical Journal of Australia fall for this? Are their reviewers incompetent, dishonest, or is there some other reason for misleading their readers with bad research?

What is acupuncture?

You stick special needles into magic qi spots on the patient’s body, in order to affect the body’s magic energy. Not mitochondrial energy. Not any real measurable energy, but some psychic powers, some Stephen King kind of energy.

Any competent/honest researcher would compare acupuncture with a valid placebo. What is a valid placebo? A valid placebo is one that the patient believes is the treatment being studied. If the treatment comes in a pill, you provide a pill that is indistinguishable from the pill, but without the active ingredient. If the treatment is to jab you with needles, you provide an experience that is indistinguishable from the needles, but without influencing any mechanism of action the proponents claim makes the needles work.

How do we get people to believe they are being stabbed with needles in magic qi spots, without actually stabbing them with needles in magic qi spots? Use toothpicks at spots that acupuncture specialists specify are definitely not magic qi spots.

Every study of acupuncture that has used a valid placebo has failed to show benefit over placebo.[2],[3],[4],[5],[6],[7],[8],[9]

Does this study use a valid placebo?

No. This study uses jargon and misdirection to distract us from the only important part of this study.

This study is just propaganda.

It doesn’t matter where you put the needles.

It doesn’t matter if you use needles.

All that matters is that you believe in voodoo.

We already knew that acupuncture is merely fancy voodoo, with the needles going into the patient, rather than the doll. These researchers want us to ignore the high quality evidence and pretend that the man behind the curtain is as great and powerful as he initially claims to be.

In conclusion, acupuncture-like treatments significantly improved function in persons with chronic low back pain. However, the finding that benefits of real acupuncture needling were no greater than those of non-insertive stimulation raises questions about acupuncture’s purported mechanism of action.

Correction 01-07-2019 – This study used real acupuncture sites, but did not use real needles and the skin was not punctured. The patients outcomes were significantly better in the fake needle group.

The sham group improved significantly more than the true acupuncture group during the treatment period, but this advantage was not sustained 1 month after treatment ended. The difference in pain between sham and true acupuncture groups at the end of treatment (0.75 points on 10-point scale), although statistically significant, probably does not represent a clinically discernible difference.

An elaborate placebo is a placebo that does better than a pill, or injection, apparently because the patient has more invested in the belief the placebo will work. An injection of a placebo (saline solution) may be more effective than a pill of real pain medicine because of the ceremony involved in giving the placebo through IV (IntraVenous) access. A placebo that is more expensive tends to have more of an effect than a less expensive placebo.[1],[2]

Acupuncture requires a lot of investment on the part of the patient. A more elaborate placebo might be fire walking. I don’t know of any research on fire walking as a treatment for pain, but I would not be surprised if it is extremely effective.

We know that acupuncture is just a placebo because research shows that sham (fake/placebo) acupuncture works just as well as real acupuncture. Sham acupuncture generally means using toothpicks (rather than needles), not penetrating the skin, but always using locations that are not qi points.[3],[4]There is also a study using fake needles at the qi points.[5]*

If the essence of acupuncture is the magic of the qi points, but the same effect is produced when staying away from the qi points, the qi points are not doing anything.

This study did not use a sham acupuncture group. We have no reason to expect real acupuncture to provide more pain relief than sham acupuncture, so how should we use this information?

Should we have people providing fake acupuncture in the ED (Emergency Department)?

If so, how should we do this?

Since it is not the acupuncture, but the patient’s reaction to the ceremony of the placebo that appears to be providing the pain relief, how many different ways might we vary the treatment to improve the placebo effect?

Should we set up a fire walking pit?

What are the ethical concerns of using placebo medicine, when the placebo appears to provide similar, but safer, relief than real medicine?

What are the ethical concerns of using deception to treat patients?

Overall, 89 patients (29.3%) experienced minor adverse effects: 85 (56.6%) in morphine group and 4 (2.6%) in acupuncture group; the difference was signi ficant between the 2 groups (Table 3). The most frequent adverse effect was dizziness in the morphine group (42%) and needle breakage in the acupuncture group (2%). No major adverse effect was recorded during the study protocol. (See Table 4.)[6]

If we ignore the problems with this study and with the problem of lying to patients to make them feel better, can we expect research journals to look more like alternative medicine magazines with article titles like –

How to lie to patients, so that . . . .

What is the best scam to relieve pain?

How much integrity do we sacrifice?

Since the ED does not appear to be the source of the increase in opioid addiction, should we sacrifice any integrity in pursuit of placebo treatments?

We have an epidemic of opioid addiction because of excessive prescriptions for long-term pain.

These results are consistent with described phenomena of commercial variables affecting quality expectations1 and expectations influencing therapeutic efficacy.4 Placebo responses to commercial features have many potential clinical implications. For example, they may help explain the popularity of high-cost medical therapies (eg, cyclooxygenase 2 inhibitors) over inexpensive, widely available alternatives (eg, over-the-counter nonsteroidal anti-inflammatory drugs) and why patients switching from branded medications may report that their generic equivalents are less effective.

In conclusion, acupuncture-like treatments significantly improved function in persons with chronic low back pain. However, the finding that benefits of real acupuncture needling were no greater than those of non-insertive stimulation raises questions about acupuncture’s purported mechanism of action.

*Correction 01-08-2019 – I was wrong to include this study in those that used fake qi points. In this study real acupuncture sites were used, but not real needles, so this study only examined the justification for using needles, not the effect of the locations. The other studies[3],[4]did use fake acupuncture locations and did show that the location also does not matter.

In a twist that the acupuncturist cannot explain, the patients outcomes were significantly better in the group that did not use real needles.

The sham group improved significantly more than the true acupuncture group during the treatment period, but this advantage was not sustained 1 month after treatment ended. The difference in pain between sham and true acupuncture groups at the end of treatment (0.75 points on 10-point scale), although statistically significant, probably does not represent a clinically discernible difference.

Withholding epinephrine (adrenaline in Commonwealth countries) in cardiac arrest is still heresy. This use of epinephrine is not based on evidence of improved outcomes that matter to patients – unless the patient is a pig/dog/rat with no heart disease having an artificially produced cardiac arrest.

The Jacobs trial ways sabotaged by politicians, the media, and other opponents of science claiming that depriving patients of the standard witchcraft is unethical.[1] Using inadequately tested hunches on uninformed patients, as long as everyone else is doing it, appears to be their idea of ethical behavior. However, the Paramedic2 trial has been underway for about a year and should provide results in 2018.[2]

There probably is some benefit for cardiac arrest patients who are not having heart attacks, but we do not currently try to identify them. We also do not know what dose or frequency is best or when to give epinephrine. Paramedic2 will only be able to answer some of those questions.

Withholding ventilation is a less defended heresy, at least in Pennsylvania.

2015 Evidence Review
There is concern that delivery of chest compressions without assisted ventilation for prolonged periods could be less effective than conventional CPR (compressions plus breaths) because the arterial oxygen content will decrease as CPR duration increases.[4]

There is no evidence to support this fear, but using reason against irrational beliefs is often unsuccessful, since the irrational appeals to emotion and avoids reason.

Medical directors have been recognizing that backboards were used because of irrational fear and assumptions of benefit that were based on hunches. Therefore many medical directors now recognize the absurdity of the use of this malpractice device and discourage the use of backboards.

Pennsylvania has also removed chilled IV fluid from protocols following the failure of the treatment to improve outcomes for cardiac arrest patients, when given by EMS.

Chilled IV fluid therapeutic hypothermia does work in the hospital, but not when provided by EMS.

This is one of the reasons EMS should not automatically adopt treatments that work in the hospital. It is difficult for many in EMS to understand, but many in EMS still think that occasionally intubating a patient makes a paramedic as good as an anesthesiologist.

In general, the state of EMS is best summed up by this statement by Prachi Sanghavi –

Our current ambulance system is based on little scientific evidence.

The scary thing for patients is that many in EMS are proud of our ignorance.

Elsewhere in medicine in 2015.

Thousands of Americans travel to regions with outbreaks of Ebola and help to stop the spread of infection. This was in spite of the panic being encouraged by the scientifically illiterate. We should have welcomed them home as we welcome home out military. Both of these groups of Americans risk their lives to protect others and should be treated better. They are far more ethical than our isolationist politicians.

We learned that we need to add rats to the growing list of the non-human animals that exhibit empathy and will sacrifice to help others.[5] It appears that comparing those who opposed sending Americans to rats is unfair to the rats.

Finally, 2015 was the 100th anniversary of Albert Einstein explaining that Isaac Newton was wrong about gravity, but that is the way science improves.

PS – We also had push dose pressors added to the Pennsylvania protocols in 2015.

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

The AHA (American Heart Association) and ILCOR (International Liaison Committee on Resuscitation) will be meeting tomorrow to finalize the recommendations for the 2015 ACLS (Advanced Cardiac Life Support) guidelines. Here is the comment I submitted on the proposed recommendation for epinephrine (Adrenaline in Commonwealth countries) in cardiac arrest.

I have not received any information about where to submit SEERS comments, so I am sending this to you. Please forward it to whomever is supposed to receive comments.

Vasopressors for cardiac arrest (1. Epi v Placebo)

Consensus on Science:
For all four long term (critical) and short term (important) outcomes, we found one underpowered trial that provided low quality evidence comparing SDE to placebo (Jacobs, 2001, 1138).[1]

As a trial that is stated to be underpowered (through no fault of Dr. Jacobs),[2] is there any valid reason the Jacobs study should be considered to be superior to observational studies?

Among 534 subjects, there was uncertain benefit or harm of SDE over placebo for the critical outcomes of survival to discharge [RR 2.12, 95% CI 0.75-6.02, p=0.16] and good neurological outcome defined as CPC of 1-2 [RR 1.73, 95% CI 0.59-5.11, p=0.32].[1]

We do not have good evidence to tell us if this is harmful or beneficial and we do not have any way of determining which patients will be harmed or helped by administration of epinephrine.

However, patients who received SDE had higher rates of the two important outcomes of survival to admission [RR 1.95, 95% CI, 1.34-2.84, p=0.0004] and ROSC in the prehospital setting [RR 2.80, 95% CI 1.78-4.41, p<0.00001] compared to those who received placebo.[1]

Are these surrogate endpoints important?

How do we know?

If these surrogate endpoints are important, why is there no valid evidence to support this claim?

We have a history of being misled by surrogate endpoints. We used to bleed patients and that produced a number of clear benefits in surrogate endpoints.

Physicians observed of old, and continued to observe for many centuries, the following facts concerning blood-letting.

1. It gave relief to pain. . . . .

2. It diminished swelling. . . . .

3. It diminished local redness or congestion. . . . .

4. For a short time after bleeding, either local or general, abnormal heat was sensibly diminished.

5. After bleeding, spasms ceased, . . . .

6. If the blood could be made to run, patients were roused up suddenly from the apparent death of coma. (This was puzzling to those who regarded spasm and paralysis as opposite states; but it showed the catholic applicability of the remedy.)

We don’t do that any more, because medicine is not supposed to just create a superficial improvement.

We should not be making any recommendation to treat based on such weak evidence.

The evidence for the routine use of adrenaline is perceived to be at equipoise within the international community of resuscitation scientists requiring re-evaluation19 as suggested by this comprehensive systematic review and meta-analysis. There is a need for well-designed, placebo-controlled, and adequately powered RCTs to evaluate the efficacy of adrenaline and to determine its optimal dosing.11,16,54 The question as to the efficacy of adrenaline for OHCA remains unanswered.[4]

Since the question as to the efficacy of adrenaline for OHCA remains unanswered, we should avoid substituting a bad answer for We don’t know.

Maybe we should bring back the indeterminate class for these unanswerable questions.

Treatment Recommendation
Given the observed benefit in short term outcomes, we suggest Standard Dose Epinephrine be administered to patients in cardiac arrest.(weak recommendation, low quality)[1]

The benefit is considered important, but that is just an expert opinion, which is the lowest level of evidence.

A weak recommendation to give a treatment of unknown benefit and unknown harm, based on evidence that is admitted to be of low quality, should not set the standard of care. Even if the guidelines are explicitly stated to not be standards of care, they are adopted as standards of care by the emergency medicine community and by the EMS community.

We don’t know enough to make a recommendation about epinephrine, or most other treatments, in cardiac arrest.

We do not need to keep making the same recommendation just because we have made it before. We can leave it up to the treating physician or to the medical director writing the protocols for EMS.

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

What do the AHA (American Heart Association) and ILCOR (International Liaison Committee on Resuscitation) plan to make their recommendation on use of epinephrine (Adrenaline in Commonwealth countries) in cardiac arrest (ACLS – Advanced Cardiac Life Support)?

Full Question:
Among adults who are in cardiac arrest in any setting (P), does does use of epinephrine (I), compared with placebo or not using epinephrine (C), change Survival with Favorable neurological/functional outcome at discharge, 30 days, 60 days, 180 days AND/OR 1 year, Survival only at discharge, 30 days, 60 days, 180 days AND/OR 1 year, ROSC (O)?

The information provided is currently in DRAFT format and is NOT a FINAL version[1]

Unless you are familiar with the way AHA/ILCOR ask questions, this may not seem to be a helpful way of addressing the question. Here is the format being used –

Everything is reasonable – until they get to the outcome. Does anyone still think that it is really an improvement to get pulses back, be transported to the hospital, never wake up, and die in the ED (Emergency Department) or ICU (Intensive Care Unit)? What if the coma lasts for 30 days, 60 days, 180 days AND/OR 1 year. If you think that is an improvement, you may not have considered the cost. How much is it worth to give a family false hope? $10,000? Who pays for this deception?

Should we also try putting the patient in a helicopter to see if the magic rotor blades make the family feel that everything possible was done to deceive them?

These are considered to be important, because we do not seem to know what is important.

Why are ROSC and survival to admission considered important?

Where is the evidence that these measurements lead to better outcomes?

Studies that look at these outcomes show that real world patients treated with epinephrine are more likely to die in the hospital – and those who do not die in the hospital are more likely to have severe neurological impairment.

Probably, but only for some patients and we do not know which patients benefit.

Is Adrenaline harmful in cardiac arrest?

Probably, but only for some patients and we do not know which patients are harmed.

The evidence evaluation focused on the Jacobs study,[8] which is randomized and placebo controlled, but only reaches the level of fair according to the analysis of all of the evidence. The reason is that politicians and the media combined to sabotage the study. Most of the ambulance services dropped out of the Jacobs study because of this interference. This is not the fault of Dr. Ian G. Jacobs, who deserves credit for setting up the first randomized placebo controlled study of this important topic.

For all four long term (critical) and short term (important) outcomes, we found one underpowered trial that provided low quality evidence comparing SDE to placebo (Jacobs, 2001, 1138).[1]

We need to bring back the Indeterminate class of recommendation for ACLS, because that is the best that we can come up with for epinephrine, unless we ignore the evidence or we just don’t understand the evidence.

Table 3.
Applying Classification of Recommendations and Level of Evidence

. . .

Class Indeterminate.• Research just getting started• Continuing area of research• No recommendations until further research (eg, cannot recommend for or against)[11]

Does the proposed ACLS recommendation on epinephrine makes sense?

Consider that we do not know which patients benefit from epinephrine. The treatment for every cause of cardiac arrest includes epinephrine as the first drug, even if the cause of cardiac arrest is known to be an overdose of epinephrine.

Is epinephrine better than nothing for some patients in cardiac arrest? Yes.

Is epinephrine worse than nothing for some patients in cardiac arrest? Yes.

We do not know which patients we are harming with epinephrine and we don’t seem to want to stop harming those patients.

CONCLUSION: There are few studies that compare vasopressors to placebo in resuscitation from cardiac arrest. Epinephrine is associated with improvement in short term survival outcomes as compared to placebo, but no long-term survival benefit has been demonstrated. Vasopressin is equivalent for use as an initial vasopressor when compared to epinephrine during resuscitation from cardiac arrest. There is a short-term, but no long-term, survival benefit when using high dose vs. standard dose epinephrine during resuscitation from cardiac arrest. There are no alternative vasopressors that provide a long-term survival benefit when compared to epinephrine. There is limited data on the use of vasopressors in the pediatric population.

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

Ignorance is preferable to error; and he is less remote from the truth who believes nothing, than he who believes what is wrong.

- Thomas Jefferson

Notes on the State of Virginia (1781-1783)

-

Bigotry and science can have no communication with each other, for science begins where bigotry and absolute certainty end. The scientist believes in proof without certainty, the bigot in certainty without proof. Let us never forget that tyranny most often springs from a fanatical faith in the absoluteness of one’s beliefs.

Ashley Montagu.

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Today we rely less on superstition and tradition than people did in the past, not because we are more rational, but because our understanding of risk enables us to make decisions in a rational mode.

- Peter L. Bernstein

Against the Gods: the remarkable story of risk (1996)

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Mark my word, if and when these preachers get control of the [Republican] party, and they're sure trying to do so, it's going to be a terrible damn problem. Frankly, these people frighten me. Politics and governing demand compromise. But these Christians believe they are acting in the name of God, so they can't and won't compromise. I know, I've tried to deal with them.

Barry Goldwater.

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I think every good Christian ought to kick Falwell right in the ass.

Barry Goldwater

Said in July 1981 in response to Moral Majority founder Jerry Falwell's opposition to the nomination of Sandra Day O'Connor to the Supreme Court, of which Falwell had said, "Every good Christian should be concerned." as quoted in Ed Magnuson, "The Brethren's First Sister," Time Magazine, (20 July, 1981)

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What do you think science is? There's nothing magical about science. It is simply a systematic way for carefully and thoroughly observing nature and using consistent logic to evaluate results. Which part of that exactly do you disagree with? Do you disagree with being thorough? Using careful observation? Being systematic? Or using consistent logic?

Dr. Steven Novella.

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What progress we are making. In the Middle Ages they would have burned me. Now they are content with burning my books.

Sigmund Freud (1933)

Today the samizdat is digital and burning a copy has the opposite meaning. A little later, persecution of the Jews was once again the law - Freud's four sisters all died in concentration camps, although not by burning.

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"Can you prove that it’s impossible?” “No”, I said, “I can’t prove it’s impossible. It’s just very unlikely”. At that he said, “You are very unscientific. If you can’t prove it impossible then how can you say that it’s unlikely?” But that is the way that is scientific. It is scientific only to say what is more likely and what less likely, and not to be proving all the time the possible and impossible. To define what I mean, I might have said to him, "Listen, I mean that from my knowledge of the world that I see around me, I think that it is much more likely that the reports of flying saucers are the results of the known irrational characteristics of terrestrial intelligence than of the unknown rational efforts of extra-terrestrial intelligence." It is just more likely. That is all.

Richard Feynman.

The Character of Physical Law (1965)
chapter 7, “Seeking New Laws,” p. 165-166:

It has been over half century since Feynman explained this. The reports of flying saucers have continued, but there is still no valid evidence to support belief in flying saucers. Feynman's explanation is a good definition of unlikely.

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An ignorant mind is precisely not a spotless, empty vessel, but one that’s filled with the clutter of irrelevant or misleading life experiences, theories, facts, intuitions, strategies, algorithms, heuristics, metaphors, and hunches that regrettably have the look and feel of useful and accurate knowledge.

David Dunning - explaining the Dunning-Kruger effect.

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Treat beliefs not as sacred possessions to be guarded but rather as testable hypotheses to be discarded when the evidence mounts against them.

Philip Tetlock.

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Squatting in between those on the side of reason and evidence and those worshipping superstition and myth is not a better place. It just means you’re halfway to crazy town.

PZ Myers

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The legitimate powers of government extend to such acts only as are injurious to others. But it does me no injury for my neighbour to say there are twenty gods, or no god. It neither picks my pocket nor breaks my leg.

Thomas Jefferson.

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Imagine a world in which we are all enlightened by objective truths rather than offended by them.

Neil deGrasse Tyson

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Education is a progressive discovery of our own ignorance.

Will Durant.

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You don't use science to show that you're right,

you use science to become right.

Randall Munroe

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Just because science doesn't know everything doesn't mean you can fill in the gaps with whatever fairy tale most appeals to you.

There appears to be in mankind an unacceptable prejudice in favor of ancient customs and habitudes which allows practices to continue long after the circumstances, which formerly made them useful, cease to exist

Benjamin Franklin.

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If science proves some belief of Buddhism wrong,

then Buddhism will have to change.

Tenzin Gyatso, 14th Dalai Lama.

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Ridicule is the only weapon which can be used against unintelligible propositions. Ideas must be distinct before reason can act upon them;

Thomas Jefferson.

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Science doesn't make it impossible to believe in God.

It just makes it possible to not believe in God.

Stephen Weinberg.

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There are no forbidden questions in science,

no matters too sensitive or delicate to be probed,

no sacred truths.

Carl Sagan.

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The legitimate powers of government extend to such acts only as are injurious to others. But it does me no injury for my neighbour to say there are twenty gods, or no god. It neither picks my pocket nor breaks my leg.

Thomas Jefferson.

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It is better to not understand something true,
than to understand something false.

Neils Bohr.

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God does not play dice with the universe.

Albert Einstein

Stop telling God what to do with his dice.

response by Neils Bohr.

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All things are poison and nothing is without poison, only the dose permits something not to be poisonous.

Paracelsus.

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What is not true, as everyone knows, is always immensely more fascinating and satisfying to the vast majority of men than what is true.

H.L. Mencken.

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Every valuable human being must be a radical and a rebel, for what he must aim at is to make things better than they are.

Niels Bohr.

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How wonderful that we have met with a paradox. Now we have some hope of making progress.

Niels Bohr.

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An expert is a man who has made all the mistakes which can be made in a very narrow field.

Niels Bohr.

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Every sentence I utter must be understood not as an affirmation, but as a question.

Niels Bohr.

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Some subjects are so serious that one can only joke about them.

Niels Bohr.

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I have no special talents. I am only passionately curious.

Albert Einstein.

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Few people are capable of expressing with equanimity opinions which differ from the prejudices of their social environment. Most people are even incapable of forming such opinions.

Albert Einstein.

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Never memorize what you can look up in books.

Albert Einstein.

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The prestige of government has undoubtedly been lowered considerably by the prohibition law. For nothing is more destructive of respect for the government and the law of the land than passing laws which cannot be enforced. It is an open secret that the dangerous increase of crime in the United States is closely connected with this.

Albert Einstein.

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the chance is high that the truth lies in the fashionable direction. But, on the off-chance that it is in another direction - a direction obvious from an unfashionable view of field theory - who will find it? Only someone who has sacrificed himself by teaching himself quantum electrodynamics from a peculiar and unusual point of view; one that he may have to invent for himself. I say sacrificed himself because he most likely will get nothing from it, because the truth may lie in another direction, perhaps even the fashionable one.

If you've made up your mind to test a theory, or you want to explain some idea, you should always decide to publish it whichever way it comes out. If we only publish results of a certain kind, we can make the argument look good. We must publish both kinds of results.

If a reasonable launch schedule is to be maintained, engineering often cannot be done fast enough to keep up with the expectations of originally conservative certification criteria designed to guarantee a very safe vehicle. In these situations, subtly, and often with apparently logical arguments, the criteria are altered so that flights may still be certified in time. They therefore fly in a relatively unsafe condition, with a chance of failure of the order of a percent (it is difficult to be more accurate).

Official management, on the other hand, claims to believe the probability of failure is a thousand times less. One reason for this may be an attempt to assure the government of NASA perfection and success in order to ensure the supply of funds. The other may be that they sincerely believed it to be true, demonstrating an almost incredible lack of communication between themselves and their working engineers.

Science is a way of trying not to fool yourself. The first principle is that you must not fool yourself, and you are the easiest person to fool.

Richard Feynman.

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Science alone of all the subjects contains within itself the lesson of the danger of belief in the infallibility of the greatest teachers in the preceding generation ... Learn from science that you must doubt the experts. As a matter of fact, I can also define science another way:

Science is the belief in the ignorance of experts.

Richard Feynman.

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The only way to have real success in science, the field I’m familiar with, is to describe the evidence very carefully without regard to the way you feel it should be. If you have a theory, you must try to explain what’s good and what’s bad about it equally. In science, you learn a kind of standard integrity and honesty.

Richard Feynman.

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Some people say, "How can you live without knowing?" I do not know what they mean. I always live without knowing. That is easy. How you get to know is what I want to know.

Richard Feynman.

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I don't know anything, but I do know that everything is interesting if you go into it deeply enough.

Richard Feynman.

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So, to test the prevailing intellectual standards, I decided to try a modest (though admittedly uncontrolled) experiment: Would a leading North American journal of cultural studies . . . publish an article liberally salted with nonsense if (a) it sounded good and (b) it flattered the editors' ideological preconceptions?

Common sense in matters medical is rare, and is usually in inverse ratio to the degree of education.

William Osler.

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The greater the ignorance the greater the dogmatism.

William Osler.

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The desire to take medicine is perhaps the greatest feature which distinguishes man from animals.

William Osler.

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One of the first duties of the physician is to educate the masses not to take medicine.

William Osler.

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In the fields of observation chance favors only the prepared mind.

Louis Pasteur.

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Science knows no country, because knowledge belongs to humanity, and is the torch which illuminates the world. Science is the highest personification of the nation because that nation will remain the first which carries the furthest the works of thought and intelligence.

Louis Pasteur.

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Not far from the invention of fire must rank the invention of doubt.

Thomas Henry Huxley.

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The great tragedy of Science — the slaying of a beautiful hypothesis by an ugly fact.

Thomas Henry Huxley.

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The foundation of morality is to have done, once and for all, with lying; to give up pretending to believe that for which there is no evidence, and repeating unintelligible propositions about things beyond the possibilities of knowledge.

Thomas Henry Huxley.

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My business is to teach my aspirations to conform themselves to fact, not to try and make facts harmonise with my aspirations.

Thomas Henry Huxley.

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There must have been a time, in the beginning, when we could have said – no. But somehow we missed it.

Tom Stoppard

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All men can be criminals, if tempted; all men can be heroes, if inspired.

G. K. Chesterton

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There is no such thing on earth as an uninteresting subject; the only thing that can exist is an uninterested person.

G. K. Chesterton

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Good taste, the last and vilest of human superstitions, has succeeded in silencing us where all the rest have failed.

G. K. Chesterton

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Men become superstitious, not because they have too much imagination, but because they are not aware that they have any.

George Santayana

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If we are uncritical we shall always find what we want: we shall look for, and find, confirmations, and we shall look away from, and not see, whatever might be dangerous to our pet theories. In this way it is only too easy to obtain what appears to be overwhelming evidence in favor of a theory which, if approached critically, would have been refuted.

Karl Popper

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It is difficult to get a man to understand something, when his salary depends upon his not understanding it!

Upton Sinclair

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Freedom is what you do with what's been done to you.

Jean-Paul Sartre

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Where goods do not cross frontiers, armies will.

Frédéric Bastiat

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The ultimate result of shielding men from the effects of folly is to ﬁll the world with fools.

Herbert Spencer

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Political language — and with variations this is true of all political parties, from Conservatives to Anarchists — is designed to make lies sound truthful and murder respectable, and to give an appearance of solidity to pure wind.

George Orwell

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Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence.

John Adams

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We're not presuming the answers before we ask the questions.

Lawrence Krauss explaining how science works

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Malo Periculosam Libertatem Quam Quietum Servitium.

Better freedom with danger than peace with slavery.

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Whatever inspiration is, it's born from a continuous "I don't know."

Wislawa Szymborska

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All sorts of torturers, dictators, fanatics, and demagogues struggling for power by way of a few loudly shouted slogans also enjoy their jobs, and they too perform their duties with inventive fervor.

Well, yes, but they "know." They know, and whatever they know is enough for them once and for all.

They don't want to find out about anything else, since that might diminish their arguments' force.

Wislawa Szymborska.

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Theory helps us to bear our ignorance of fact.

George Santayana

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Miracles are propitious accidents, the natural causes of which are too complicated to be readily understood.

George Santayana.

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Fanaticism consists in redoubling your efforts when you have forgotten your aim.

George Santayana

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There is a fundamental difference between religion,

which is based on authority,

and science,

which is based on observation and reason.

Science will win because it works.

Stephen Hawking.

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The truth, indeed, is something that mankind, for some mysterious reason, instinctively dislikes. Every man who tries to tell it is unpopular, and even when, by the sheer strength of his case, he prevails, he is put down as a scoundrel.

H.L. Mencken.

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It is the natural tendency of the ignorant to believe what is not true. In order to overcome that tendency it is not sufficient to exhibit the true; it is also necessary to expose and denounce the false.

I am attempting to make it easier, when I use footnotes, to navigate to the information in a footnote, look at the information, and return to where you were before you clicked on the footnote. If you click on the number of a footnote in the text[1] <- click on the bracketed and underlined number - in this case [1], it will bring the footnote to the top of the screen.

[1] If you click on the bracketed and underlined number of a footnote in footnote section, the [1] at the beginning of this paragraph, it will take you to where you clicked on the footnote in the text, with the footnote along the top of the screen. [To top of footnotes]

If you wish to modify the size of the text, you can press the CTRL key and roll the mouse wheel forward or back, or you can press the CTRL key and the + or - keys to make text larger or smaller. Another way is to adjust the font in your browser controls.

This is a mostly medical blog, so here is the HIPAA incantation to ward off evil whiny HIPAA-obsessed spirits.

HIPAA (Health Insurance Portability and Accountability Act of 1996) is generally misrepresented by those in health care, but there are no violations of HIPAA here. There are some patients I could not discuss without changing details, so details may be omitted, or changed. That may decrease the dramatic effect of some of what I write, but patients are entitled to their privacy and have been since before HIPAA became the ignorant administrators' justification for imitating a two year old yelling NO!

I am not dispensing medical advice. If you get your medical advice off of a blog, instead of consulting a physician (such as your medical director), you probably should not be treating anyone, not even yourself. I could include your dog, but that would suggest that veterinarians do not provide excellent care. The veterinarians I know take pride in the care they deliver and deliver excellent care, more so than many people I know in EMS.

I do point you to research to support what I write, but you still need to make sure that you have the authorization of your medical director before changing any of your treatments. If your medical director does not agree, you can point to the research I write about. Most doctors do understand research, they just have trouble keeping up with the amount of research that is produced.

What I write does not change your protocols. If you do not like a protocol, take it up with the medical director. I have several inadequate protocols, too. I call medical command and attempt to persuade the physician that what I am requesting is in the best interest of the patient. It is rare that I am turned down, but the dose is often inadequate. I call back before I need more, so the patient does not have to put up with the On Line Medical Command delay in treatment. Health care providers should be anticipating where the care of the patient is headed - both for good and for bad.

I do not have any connection to the products I mention, other than using them and being satisfied, dissatisfied, or some combination of the two. If I have any potential conflict of interest, I will mention it clearly.

If I write about a book by an author I know, I will encourage you to buy the book from the author's web site. This means that any money goes to the author (or to where the author wants the money to go, such as a charity) and you have an opportunity to sample the author's writing for free on the author's blog before buying the book.

I may be blunt, but I do not intend it personally. There are few mistakes that can be made that I have not made. I continue to try not to be stupid; you may conclude that I fail.

I welcome any relevant comments and much that is not relevant. I reserve the right to delete any inappropriate comments. I decide what is appropriate based on my own nebulous standards. Criticism of ideas is expected. Criticism of writing style is appreciated.

I avoid obscenity because I believe that the English language provides enough opportunities for creativity that resorting to the words that may not be said on TV (and a growing group of words that may) is unnecessary. I may quote something that contains some of these words, or I may link to something that does, but that is as bad as I expect to be with these words.

On the other hand, you may feel that the ideas I present are offensive. My aim is to encourage thought, dialogue, and creativity - not to tell you everything is OK. You may leave this blog at any time and bury your mind in comfortable, familiar ideas.

If you feel that the ideas I present are not challenging, please encourage me to address whatever you feel I do not adequately address.